Background

The treatments based on motor control and motor learning principles have gained popularity in the last 20 years, as well as non-invasive brain stimulations that enhance neuroplastic changes after stroke. However, the effect of intermittent theta burst stimulation (iTBS) in addition to evidence-based, intensive neurorehabilitation approaches such as modified constraint-induced movement therapy (mCIMT) is yet to be investigated.

Aim

We aim to establish a protocol for a randomized controlled study investigating the efficiency of mCIMT primed with iTBS after stroke.

Methods

In this randomized controlled, single-blind study, patients with stroke (N = 17) will be divided into 3 groups: (a) mCIMT + real iTBS, (b) mCIMT + sham iTBS, and (c) mCIMT alone. 600-pulse iTBS will be delivered to the primary motor cortex on the ipsilesional hemisphere, and then, patients will receive mCIMT for 1 h/session, 3 sessions/week for 5 weeks. Upper extremity recovery will be assessed with Fugl-Meyer Test-Upper Extremity and Wolf Motor Function Test. Electrophysiological assessments, such as Motor-Evoked Potentials, Resting Motor Threshold, Short-Intracortical Inhibition, and Intracortical Facilitation, will also be included.

Conclusions

In this study, a protocol of an ongoing intervention study investigating the effectiveness of iTBS on ipsilesional M1 prior to the mCIMT in patients with stroke is proposed. This will be the first study to research priming mCIMT with iTBS and it may have the potential to reveal the true effect of the iTBS when it is added to the high-quality neurorehabilitation approaches.

Trial registration

Trial registration number: NCT05308667

中文翻译：

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通过间歇性 theta 爆发刺激启动约束诱导运动疗法以增强中风患者上肢恢复：随机对照研究方案

背景

基于运动控制和运动学习原理的治疗方法以及增强中风后神经可塑性变化的非侵入性脑刺激在过去 20 年中越来越受欢迎。然而，除了基于证据的强化神经康复方法（例如改良约束诱导运动疗法（mCIMT））之外，间歇性θ爆发刺激（iTBS）的效果还有待研究。

目的

我们的目标是建立一项随机对照研究方案，调查中风后用 iTBS 启动的 mCIMT 的效率。

方法

在这项随机对照、单盲研究中，中风患者 ( N  = 17) 将被分为 3 组：(a) mCIMT + 真实 iTBS、(b) mCIMT + 假 iTBS 和 (c) 单独 mCIMT。 600 脉冲 iTBS 将传递至同病半球的初级运动皮层，然后患者将接受 mCIMT，每次 1 小时，每周 3 次，持续 5 周。上肢恢复情况将通过 Fugl-Meyer 上肢测试和 Wolf 运动功能测试进行评估。电生理学评估，如运动诱发电位、静息运动阈值、短期皮质内抑制和皮质内促进也将包括在内。

结论

在本研究中，提出了一项正在进行的干预研究方案，该研究方案旨在调查中风患者 mCIMT 之前 iTBS 对同位 M1 的有效性。这将是第一项研究用 iTBS 启动 mCIMT 的研究，当将 iTBS 添加到高质量的神经康复方法中时，它可能有潜力揭示 iTBS 的真正效果。

试用注册

试用注册号：NCT05308667